# Diagnostic Automation/ Cortez Diagnostics Inc,. (manufacturer, Woodland Hills, CA): 6 new FDA device listings, incl. radioimmunoassay, estrone

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Diagnostic Automation/ Cortez Diagnostics Inc,. |
| Owner / operator | Diagnostic Automation /Cortez Diagnostics Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device; Manufacture Device in the United States for Export Only; Repack or Relabel Medical Device |
| Location | Woodland Hills, CA, US |
| New listings | 6 |
| Devices | Radioimmunoassay, Estrone; Reagents, Cysticercosis; Enzyme Linked Immunoabsorbent Assay, Mumps Virus; Blood, Occult, Colorimetric, In Urine; Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users; Devices Detecting Influenza A, B, And C Virus Antigens |
| Product codes | CGF, MDJ, LJY, JIO, SEA, PSZ |
| Device classes | Class I, Class II |
| Medical specialties | Clinical Chemistry, Microbiology, Hematology |
| Brand names | AccuDiag™ Estrone ELISA; AccuDiag™ Enhanced Toxocara IgG ELISA; AccuDiag™ Mumps IgM Elisa; URS-1B; OneStep HBsAg /HCV /HIV /Syphilis Combo RapidCard InstaTest; Onestep Flu A & B Antigen RapiCard™ InstaTest |
| First new listing | 2026-05-28 |
| Latest new listing | 2026-08-19 |
| FDA registration number | 2029372 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.